ANZCTR search results

The purpose of this study is to compare a new imaging technique (called 18F-DCPYL-PET/CT) to standard imaging. Who is it for? You may be eligible for this study if you are a male aged 18 or older and are due for imaging to see if you have prostate cancer. Study details All participants in this study will have two scans. One is a multi-parametric magnetic resonance imaging (mpMRI) scan, which is the standard imaging technique used. The other scan is a Positron Emission Tomography (PET) scan, which will be combined with a technique called computed tomography (CT). The PET scan required injection of a chemical called 18F-DCPYL, using a needle in the arm. Researchers will use the results of these scans to see if the 18F-DCPYL scan is as useful as the mpMRI. As part of the study, participants will consent to access medical records, in addition to the scans. It is hoped this research will demonstrate the 18F-DCPYL scan can improve our ability to detect prostate cancer.

Achieving optimal health for people with CD requires a strict gluten free diet. Unfortunately, accidental gluten intake is common. Assessing for gluten intake based on dietitian evaluation or coeliac serology lacks sensitivity and small intestinal histology requires an invasive test. This study will assess a new test that measures gluten (gluten immunogenic peptides) in a faecal (stool) sample. Participants will consume a gluten-free cookie containing either a small amount of gluten (equivalent to a “real-world” contamination) or placebo and their faeces assessed. The study will inform how this objective test can be deployed in clinical practice to support people following a strict gluten free diet.

This study aims to determine the best way of delivering radiation therapy to the breast tissue before surgery. In order to do that, women will lay in a prone position (on the stomach), so that the breast can fall naturally forward and away from the chest. The cancer inside the breast tissue is treated to a very high dose before it is removed. The aim is to minimise skin toxicities to help the surgeons perform the operation and reconstruction, all in one surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have a histologically confirmed invasive, Grade 1, 2 or 3 breast carcinoma with a Primary tumour graded as T2, T3 or T4 and N1+. Study details This study will take about 1 year to recruit 20 participants suitable for radiotherapy in the prone position. On average, the total study duration is expected to be 3 months for each participant. Radiotherapy treatment will commence at least 4 weeks after completion of standard chemotherapy and it will be delivered in the prone position, five days a week from Monday to Friday, over 5 weeks (25 fractions, 2Gy/fraction). One week before the radiotherapy treatment, the Radiotherapy Planning will be booked and the session will take approximately 1 hour. During the study, clinical assessments will be performed once a week during the treatment and then 2 and 4 weeks after radiotherapy completion. Each visit will take approximately 1 hour. 4-8 weeks following successful completion of radiotherapy participant will have a surgery to remove the breast and immediate breast reconstruction. 30 days after the surgery each patient will have their last study visit - post surgical assessment to evaluate any side effects and surgical complications. It is hoped that information from this study may help improve the treatment for other patients with invasive type of breast cancer in the future and will help evaluate the new position and treatment doses for future breast radiotherapy treatment.

Evaluating the impact of the Smileyscope will assist participating health services in determining the ongoing adoption of the technology for routine clinical use. The evaluation will also inform other Kimberley health services about the impact and acceptability of Smileyscope for Aboriginal children, their families, and their healthcare professionals helping to create regional discussions and approaches to paediatric needle pain and anxiety management.

Children with cerebral palsy (CP) participate less in physical activity and have high levels of sedentary behaviour (sitting still) compared to children without CP. Our aim is to pilot a physical activity behaviour-change intervention in 12 children with CP under eight years old. Our trial is innovative because it aims to intervene earlier in the development of sedentary behaviour and will be the first to include children who cannot walk independently. The intervention is grounded in evidence-based theories of health behaviour change. The 8 week face-to-face, highly tailored intervention will be delivered by a paediatric physiotherapist or occupational therapist, with the aim to increase participation in community physical activities and reduce sedentary behaviour. It is important that we pilot some of the outcome measures to be used in the trial including accelerometers, because we don’t have good information about their ability to detect change in this population. Anticipated outcomes of this project will include: information about the feasibility and tolerability of the intervention and outcome measurement; pilot evidence of how effective the therapy is; and information about the behaviour-change mechanism of the intervention.

Recent preliminary findings suggest markers of neuronal damage (neurofilament light and tau) are associated with general anesthesia and surgery, which in turn may be associated with the clinical outcomes of delirium and postoperative cognitive dysfunction. Specifically, in a pilot study we observed that people undergoing cardiac surgery showed greater increases in plasma neurofilament light and tau than those undergoing non-cardiac surgery. The aim of this investigation is to compare the plasma levels of NFL and tau after cardiac compared to non-cardiac surgery and relate these levels to the subsequent neurocognitive outcomes in the postoperative period. Cognitive and memory testing will take place prior to surgery, at 7 days after surgery and at 3 months after surgery. Tests for delirium and collection of blood samples will also be conducted during the participants' time in hospital.

Intradermal delivery of insulin has been shown to be safe, well tolerated and to improve the pharmacokinetics of rapid insulin analogs compared with conventional subcutaneous administration in patients with type 1 diabetes and type 2 diabetes as well as in healthy individuals. It is associated with more rapid insulin absorption with faster time to maximum insulin concentration and faster offset of action compared to subcutaneous insulin administration. Med-Jet H4 (Medical International Technologies Canada, Montreal, Quebec, Canada) is a needle-free injector device which can deliver the drugs intradermally. The Purpose of this study is to compare the pharmacokinetics, pharmacodynamics, safety and tolerability of insulin aspart delivered by intradermal injection with Med-Jet H4 device versus subcutaneous injection with FlexPen® in healthy non-diabetic individuals.

The primary aim of this study was to determine if the addition of concurrent visual feedback, via a tablet computer, would increase adherence to an upper limb home exercise program in people with stroke. A secondary aim was to assess the feasibility of use of upper limb accelerometry as a method of monitoring upper limb activity during a home exercise program in people with stroke.

No study has compared post-procedural body composition and bone density changes via dual-energy X-ray absorptiometry (DXA) for patients electing bariatric surgery in Australia. This prospective cohort study, aims to: 1) test the feasibility and acceptability of conducting bone mineral density and body composition assessment via DXA scan at pre-procedure, 6-months and 12-months post-procedure; and 2) compare bone mineral density and body composition changes relative to weight loss over 12-months. It is hypothesised that loss of bone mineral density will be evident by 12-months post-procedure, particularly in females and that both fat mass and lean mass will reduce over the 12-months post-procedure

A recent Australia-wide survey found that many general practitioners recommend unnecessary imaging and surgical referrals for a common type of shoulder pain (rotator cuff tendinopathy). We hypothesise that educating patients with rotator cuff related pain directly about their condition and recommended care has the potential to reduce inappropriate imaging and surgery, increase adherence to recommended care and ultimately improve healthcare outcomes. The proposed study is a three-arm, parallel group, pilot and feasibility randomised controlled trial. Participants will be randomised to one of three trial arms; Group (i) standard advice and exercise via online printable pamphlet (comparator); (ii) A combination of online printable pamphlet and video, plus a "virtual physiotherapist" whereby participants enter their exercise and symptoms into the website and it tailors their exercise; (iii) A combination of online printable pamphlet, video and "virtual physiotherapist" plus a weekly telerehabilitation session with a physiotherapist.